HIVNCT05025891
ISe-santé, a Study Evaluating a Model for Implementing E-health in the Management of HIV Patients
A study testing Teleconsultation in people with HIV and Telemedicine, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Telemedicine
- What is being tested?
- Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 4 Feb 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic HIV infection.
- Patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the Cayenne Hospital Center.
- Patient of legal age.
- Patient having signed the consent form..
Who cannot join
- Pregnant patient
- Patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability).
- Patient with a physical disability that prevents communication via the e-Health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient).
- Patient who does not master one of the languages available at the mediation.
- Patients under guardianship or trusteeship, people under protective measures
Trial locations and contacts
1 site in 1 country.
BOUTROU Mathilde, Dr contact
French Guiana1 site, 1 recruiting
- Recruiting
General Hospital of Cayenne
Cayenne, 97306
Mathieu Nacher, Pr, 0594395385, mathieu.nacher@ch-cayenne.fr
About this study
Official title: Reducing Inequalities in Access to Care in French Guiana: ISe-santé, a Randomized Study Evaluating a Model for Implementing E-health in the Management of HIV
It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.
Read the detailed description
The COVID-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. In this context, e-Health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with COVID 19, to protect patients and caregivers and avoid nosocomial infections. Telemedicine is all the more relevant in Guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. In French Guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak French and having restricted access to digital technology. Moreover HIV infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment.
The study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital : 1/ Control group with classic follow-up at Cayenne hospital. 2/Teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/Teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator Patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). Number of patients to be included: 450 patients.
- Conditions
- HIV, Telemedicine
- Being tested
- Teleconsultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationOther
Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: control | No intervention | Patients continue consultations as usual in HDJA or at UMIT. |
| Arm 2: teleconsultation alone | Experimental | Patients are directed to the tele-monitoring platform without specific accompaniment. Receives: Other: Teleconsultation |
| Arm 3: teleconsultation and mediation | Experimental | Patients are referred to the tele-monitoring platform with specific support with mediation. Receives: Other: Teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportions of patients who followed the schedule proposed by the physician at inclusion (or revised during important events) in the 3 arms.
Measured: The inclusion period (1 year)
Secondary outcomes (14)
Identification of the best strategy for implementing an e-Health platform in French Guiana in the management of chronic HIV infection
Measured: The inclusion period (1 year)
The proportion of patients throughout the inclusion period (1 year) likely to use the platform will be assessed using the number of patients meeting the inclusion criteria (having agreed to participate in the research or not).
Measured: The inclusion period (1 year)
The obstacles to the use of an e-health platform will be evaluated using a questionnaire for caregivers and patients and based on the number of failed connections
Measured: The inclusion period (1 year)
Patient satisfaction score assessed with study specific questionnaire
Measured: The inclusion period (1 year)
Caregiver satisfaction score assessed with study specific questionnaire
Measured: The inclusion period (1 year)
Evaluation of the material needs to guarantee accessibility of the consultation places
Measured: The inclusion period (1 year)
Evaluation of the material needs for the implementation and maintenance of the e-health platform
Measured: The inclusion period (1 year)
Measurement of the average intervention time of the doctors per patient
Measured: The inclusion period (1 year)
Measurement of the average intervention time of the mediators per patient
Measured: The inclusion period (1 year)
Measurement of the average intervention time of the ETP nurse per patient
Measured: The inclusion period (1 year)
Compare the patients followed up with the platform and the patients followed up in classic consultation on: the proportion of check-ups done during the same duration of follow-up, the proportion of patients with an undetectable viral load, the proportion
Measured: The inclusion period (1 year)
proportion of check-ups done during the same duration of follow-up between patients followed up with the platform and the patients followed up in classic consultation
Measured: The inclusion period (1 year)
proportion of patients with an undetectable viral load between patients followed up with the platform and the patients followed up in classic consultation
Measured: The inclusion period (1 year)
Questionnaire for all the care providers assessed with study specific questionnaire
In order to evaluate the number of patients lost to follow-up, service congestion, patient waiting time, knowledge of the patient's pathway, communication with the patient, the number of missed consultations and the viral load of patients followed via the platform.
Measured: The inclusion period (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start4 Feb 2021
- Primary completion4 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025891
- Sponsor's protocol ID
- ISe-SANTE
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inequalities in Access to Care in French Guiana: ISe-santé, a Randomized Study Evaluating a Model for Implementing E-health in the Management of HIV
- ClinicalTrials.gov ID
- NCT05025891
- Acronym / sponsor ID
- ISe-SANTE
- Conditions
- HIV, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 4 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.
Detailed description
The COVID-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. In this context, e-Health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with COVID 19, to protect patients and caregivers and avoid nosocomial infections. Telemedicine is all the more relevant in Guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. In French Guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak French and having restricted access to digital technology. Moreover HIV infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment.
The study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital : 1/ Control group with classic follow-up at Cayenne hospital. 2/Teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/Teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator Patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). Number of patients to be included: 450 patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: control | No intervention | –Patients continue consultations as usual in HDJA or at UMIT. |
| Arm 2: teleconsultation alone | Experimental | Other: TeleconsultationPatients are directed to the tele-monitoring platform without specific accompaniment. |
| Arm 3: teleconsultation and mediation | Experimental | Other: TeleconsultationPatients are referred to the tele-monitoring platform with specific support with mediation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic HIV infection.
- Patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the Cayenne Hospital Center.
- Patient of legal age.
- Patient having signed the consent form..
Key exclusion criteria (5 listed)
- Pregnant patient
- Patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability).
- Patient with a physical disability that prevents communication via the e-Health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient).
- Patient who does not master one of the languages available at the mediation.
- Patients under guardianship or trusteeship, people under protective measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultationPatients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care | Other | Arm 2: teleconsultation alone, Arm 3: teleconsultation and mediation |
Primary outcome
Comparison of the proportions of patients who followed the schedule proposed by the physician at inclusion (or revised during important events) in the 3 arms.
Time frame: The inclusion period (1 year)
14 secondary outcomes
Identification of the best strategy for implementing an e-Health platform in French Guiana in the management of chronic HIV infection
Time frame: The inclusion period (1 year)
The proportion of patients throughout the inclusion period (1 year) likely to use the platform will be assessed using the number of patients meeting the inclusion criteria (having agreed to participate in the research or not).
Time frame: The inclusion period (1 year)
The obstacles to the use of an e-health platform will be evaluated using a questionnaire for caregivers and patients and based on the number of failed connections
Time frame: The inclusion period (1 year)
Patient satisfaction score assessed with study specific questionnaire
Time frame: The inclusion period (1 year)
Caregiver satisfaction score assessed with study specific questionnaire
Time frame: The inclusion period (1 year)
Evaluation of the material needs to guarantee accessibility of the consultation places
Time frame: The inclusion period (1 year)
Evaluation of the material needs for the implementation and maintenance of the e-health platform
Time frame: The inclusion period (1 year)
Measurement of the average intervention time of the doctors per patient
Time frame: The inclusion period (1 year)
Measurement of the average intervention time of the mediators per patient
Time frame: The inclusion period (1 year)
Measurement of the average intervention time of the ETP nurse per patient
Time frame: The inclusion period (1 year)
Compare the patients followed up with the platform and the patients followed up in classic consultation on: the proportion of check-ups done during the same duration of follow-up, the proportion of patients with an undetectable viral load, the proportion
Time frame: The inclusion period (1 year)
proportion of check-ups done during the same duration of follow-up between patients followed up with the platform and the patients followed up in classic consultation
Time frame: The inclusion period (1 year)
proportion of patients with an undetectable viral load between patients followed up with the platform and the patients followed up in classic consultation
Time frame: The inclusion period (1 year)
Questionnaire for all the care providers assessed with study specific questionnaire
Time frame: The inclusion period (1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOUTROU Mathilde, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation in people with HIV and Telemedicine, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUCARELLI Aude, Dr (0594395541, aude.lucarelli@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportions of patients who followed the schedule proposed by the physician at inclusion (or revised during important events) in the 3 arms. (time frame: The inclusion period (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.